This application proposes to assess the societal impact of genetic tests offered directly to consumers (DTC) and to develop policy options for DTC oversight that will balance the benefits of promoting availability of tests that can have a positive impact on public health and preventing harm to the public as a result of misleading claims, inappropriate tests, or inaccurate test results. DTC genetic testing challenges the traditional means of genetic test delivery. Some argue that genetic testing should take place only in the context of a health care provider, and that DTC genetic testing may harm consumers through inappropriate test selection, lack of counseling, and improper test interpretation. Others argue that DTC genetic testing may increase consumer awareness of, and access to, tests that can help them improve their health and make beneficial treatment and lifestyle decisions. Little is known about the legal or business landscape for genetic testing or its likely impact of DTC genetic testing on consumer behavior. Supporting research to ensure the effective and appropriate translation of genetics research to the public is a cornerstone of the ELSI program. The success of the Human Genome Project has led to the development of genetic tests for more than 1,200 diseases. A growing number of these tests are being offered DTC and there are few regulatory barriers to market entry. Therefore, we may expect to see significant growth of DTC genetic testing in the near future. The National Human Genome Research Institute has raised several significant research questions about DTC genetic testing. This project will provide the data needed to begin to answer some of these questions. It will develop a comprehensive landscape analysis of the DTC environment. It will evaluate claims for specific tests offered DTC and compare these claims to evidence of validity and utility in scientific literature. It will assess public awareness and attitudes regarding DTC genetic testing services and the experiences of consumers who have used two different DTC tests. Finally, it will develop policy options for oversight of DTC genetic testing. In all of these activities, the GPPC will serve as an expert resource for policymakers, the media and the public about DTC genetic testing. PUBLIC HEALTH REVELANCE STATEMENT This project is directly relevant to the health of the U.S. public. Advances in genomics have significant potential to benefit public health, but only if the public makes informed choices about whether to obtain genetic testing and what actions to take based on test results. The recent growth in direct-to-consumer (DTC) genetic testing presents questions, concerns, and opportunities, but little is known about its impact. Achieving the specific aims proposed of this project will provide the data and analysis needed for informed policy development for DTC genetic testing and important insights that can contribute to ensuring effective translation of discoveries in genetic research so as to benefit the public's health.